Sanuwave Health Inc., a medical technology company, focuses on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area for the repair and regeneration of tissue, musculoskeletal, and vascular structures. Today the company announced dermaPACE® will be highlighted in a Continuing Medical Education (CME) accredited presentation at the American Podiatric Medical Association (APMA) 2011, which is to be held July 26-28 in Boston. Podiatrists are doctors who provide treatment for conditions that affect the ankle and foot, which includes soft tissue disorders such as diabetic foot ulcers.
The presentation, which is titled “Pulsed Acoustic Cellular Expression Technology in the Treatment of Diabetic Foot Ulcers: A Sham-controlled, Double-blinded, Randomized Clinical Trial,” will be held on Thursday, July 28 from 2:30-3:00 p.m. Eastern time. The presentation will showcase and expand upon the dermaPACE pivotal phase III clinical trial results, which includes: dermaPACE subjects reached a statistical significance in 100% wound closure compared to Sham-control beginning at 20 weeks (p=0.018) and continuing on through 24 weeks (p=0.022); within the 6 weeks that followed the initial dermaPACE procedure, and consistently throughout the 24-week analysis period, dermaPACE has drastically decreased the size of the ulcer compared with subjects randomized to receive Sham-control; dermaPACE was linked with an extremely low rate of ulcer recurrence at a 24 week mark (4.5%); and dermaPACE was shown to have an excellent safety profile, which includes a reduction in infection.
The presentation will be delivered by Vickie R. Driver, DPM, MS, FACFAS; Associate Professor of Surgery; Director, Clinical Research Limb Preservation and Wound Healing; and Director, Research Fellowship and International Scholars Program, Boston University Medical Campus and Boston University School of Medicine, and one of the principal investigators on the recently concluded Phase III, Investigational Device Exemption (IDE) clinical trial for dermaPACE for the treatment of diabetic foot ulcers.
SANUWAVE Health will be displaying dermaPACE and the strongly compelling clinical data from its Phase III clinical trial about the diabetic foot ulcers at Exhibit Booth #620 throughout the meeting.
Christopher M. Cashman, President and Chief Executive Officer of SANUWAVE, said, “The results for dermaPACE are compelling. Diabetic foot ulcers treated with dermaPACE, in general, immediately stabilized and did not worsen. These ulcers quickly reduced in size and continued to full closure in a significantly greater proportion than ulcers in the comparative Sham-control group. Ulcers closed with dermaPACE didn’t tend to recur, and dermaPACE procedures were shown to be safe and were associated with a lower overall incidence of infection.”
“We already know that dermaPACE procedures can be delivered at a much lower cost to the healthcare system than existing advanced wound treatment modalities – and with improved ease of use and convenience for both clinicians and patients. These highly positive dermaPACE study results complete the picture and position dermaPACE well for early adoption and widespread utilization. We are pleased to have these results presented in the first nationally accredited CME presentation at an annual scientific meeting,” concluded Mr. Cashman.
For more information on Sanuwave Health, Inc. visit their company website: www.sanuwave.com
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